Layered braided aneurysm treatment device with corrugations

ABSTRACT

An implant including an open end and a pinched end can have a predetermined shape. When in the predetermined shape, the tubular braid can include a proximal inversion and two segments, and the braid can be composed of one or more wires. The first segment can extend from the open end of the tubular braid to the proximal inversion. The second segment can be at least partially surrounded by the open end and extend from the proximal inversion to the pinched end. The tubular braid can also include at least one corrugated fold. The one or more corrugated folds can be located within the first segment, second segment, or both. The corrugated folds can be configured to assist in anchoring the example device when in the implanted shape within an aneurysm in a similar manner to stent struts to help the tubular braid hold its shape.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 16/748,877 filed Jan. 22, 2020, which is acontinuation-in-part of U.S. patent application Ser. No. 16/418,199filed May 21, 2019. The present application is also acontinuation-in-part of U.S. patent application Ser. No. 16/853,135filed Apr. 20, 2020. The contents of all of which are incorporatedherein by reference in their entirety as if set forth herein.

FIELD OF INVENTION

The present invention generally relates to medical instruments, and moreparticularly, to embolic implants for aneurysm therapy.

BACKGROUND

Cranial aneurysms can be complicated and difficult to treat due to theirproximity to critical brain tissues. Prior solutions have includedendovascular treatment whereby an internal volume of the aneurysm sac isremoved or excluded from arterial blood pressure and flow. Currentalternatives to endovascular or other surgical approaches can includeintravascularly delivered treatment devices that fill the sac of theaneurysm with embolic material or block the entrance or neck of theaneurysm. Both approaches attempt to prevent blood flow into theaneurysm. When filling an aneurysm sac, the embolic material clots theblood, creating a thrombotic mass within the aneurysm. When treating theaneurysm neck, blood flow into the entrance of the aneurysm isinhibited, inducing venous stasis in the aneurysm and facilitating anatural formation of a thrombotic mass within the aneurysm.

Current intravascularly delivered devices typically utilize multipleembolic coils to either fill the sac or treat the entrance of theaneurysm. Naturally formed thrombotic masses formed by treating theentrance with embolic coils can result in improved healing compared toaneurysm masses packed with embolic coils because naturally formedthrombotic masses can reduce the likelihood of distention from arterialwalls and facilitate reintegration into the original parent vessel shapealong the neck plane. However, embolic coils delivered to the neck ofthe aneurysm can potentially have the adverse effect of impeding theflow of blood in the adjoining blood vessel, particularly if theentrance is overpacked. Conversely, if the entrance is insufficientlypacked, blood flow can persist into the aneurysm. Treating certainaneurysm morphology (e.g. wide neck, bifurcation, etc.) can requireancillary devices such a stents or balloons to support the coil mass andobtain the desired packing density. Once implanted, the coils cannoteasily be retracted or repositioned. Furthermore, embolic coils do notalways effectively treat aneurysms as aneurysms treated with multiplecoils often recanalize or compact because of poor coiling, lack ofcoverage across the aneurysm neck, blood flow, or large aneurysm size.

Alternatives to embolic coils are being explored, for example a tubularbraided implant is disclosed in US Patent Publication Number2018/0242979, incorporated herein by reference. Tubular braided implantshave the potential to easily, accurately, and safely treat an aneurysmor other arterio-venous malformation in a parent vessel without blockingflow into perforator vessels communicating with the parent vessel.Compared to embolic coils, however, tubular braided implants are a newertechnology, and there is therefore capacity for improved geometries,configurations, delivery systems, etc. for the tubular braided implants.For instance, delivery of tubular braided implants can require uniquedelivery systems to prevent the braid from inverting or abrading whenpushed through a microcatheter, and some simple delivery systems thatpush embolic coils through microcatheters from their proximal end maynot be effective to deliver tubular braids.

There is therefore a need for improved methods, devices, and systems forimplants for aneurysm treatment.

SUMMARY

It is an object of the present invention to provide systems, devices,and methods to meet the above-stated needs. Generally, it is an objectof the present invention to provide a braided implant that can securewithin an aneurysm sac and occlude a majority of the aneurysm's neck.The implant can include a tubular braid that can be set into apredetermined shape, compressed for delivery through a microcatheter,and implanted in at least one implanted position that is based on thepredetermined shape and the geometry of the aneurysm in which the braidis implanted. The tubular braid can include a single layer of braidedmaterial or two or more layers of braided material constricted togetherat a pinched end. The tubular braid can also include one or morecorrugated folds. The wire of the braid along the corrugated folds canbe flatter relative to the wire in other portions of the braid.

In some examples presented herein, when compressed, the implant can besufficiently short to mitigate friction forces produced when the implantis delivered unsheathed through the microcatheter allowing for a moresimplistic delivery system compared to some other known braided embolicimplant delivery systems.

In some examples presented herein, when the implant is implanted, amajority of the aneurysm sac can be free from embolic material tofacilitate the formation of a thrombotic mass that is primarilynaturally formed. Percentage of volume of the aneurysm sac filled withembolic material can be controlled by adding more layers of braidedmaterial that are constricted together at the pinched end. Additionallayers of braided material can also serve to provide a denser barrier toocclude blood flow into the aneurysm neck.

In some examples presented herein, the tubular braid can be implanted intwo distinct implanted shapes, depending on the size of the aneurysm,allowing for treatment of a wider range of aneurysm sizes compared tosome other known braided embolic implants.

In some examples presented herein, when implanted, the tubular braid canhave a compaction resistant column extending across a majority of theheight of the aneurysm and positioned centrally within the aneurysm sac.

An example implant can include two layers (layer A and layer B) oftubular braid constricted together at a pinched end. The two layers caneach have a predetermined shape in which each of the two layersrespectively has a first and second inversion and a first, second, andthird segment. The third segment extends from the pinched end to thesecond inversion. The second segment extends from the second inversionto the first inversion and at least partially surrounds the thirdsegment. The first segment extends from the first inversion and at leastpartially surrounds the second segment.

For each of the two layers, the first segment can only partiallysurround the second segment.

One of the two braid layers can lack any radiopaque wire. The other ofthe two braid layers can include a radiopaque wire.

The two layers of tubular braid can be stable in a first implanted shapebased on the predetermined shape when constrained by a firstsubstantially spherical cavity. The two layers of tubular braid can bestable in a second implanted shape based on the predetermined shape whenconstrained by a second substantially spherical cavity. In each of thefirst implanted shape and the second implanted shape, each of the twolayers can include an outer layer corresponding to the first segment ofthe predetermined shape and a proximal inversion corresponding to thefirst inversion of the predetermined shape.

In the first implanted shape, the outer layer of layer A can bepositioned to contact a cavity wall of the first substantially sphericalcavity, the outer layer of layer B apposes the outer layer of layer A,and the proximal inversion of each of the two layers can be positionedto be placed approximate an entrance to the first substantiallyspherical cavity. In the first implanted shape, each of the two layersof tubular braid can include a sack corresponding to the second segmentof the predetermined shape. The sack of layer B can be positioned toappose a portion of a cavity wall of the first substantially sphericalcavity and the sack of layer A can be contained within the sack of layerB.

In the second implanted shape, the outer layer of layer A can bepositioned to contact a cavity wall of the second substantiallyspherical cavity, the outer layer of layer B can be positioned to apposethe outer layer of layer A, and the proximal inversion of each of thetwo layers can be positioned to be placed approximate an entrance to thesecond substantially spherical cavity. In the second implanted shape,each of the two layers of tubular braid can include a middle layer andinner layer corresponding to the second segment of the predeterminedshape and a fold separating the middle and inner layer such that theinner layer of layer B apposes the inner layer of layer A which apposesthe middle layer of layer A which apposes the middle layer of layer Bwhich apposes the outer layer of layer B.

In the predetermined shape, each of the two layers of tubular braid caninclude a bend positioned in the second segment. In the second implantedshape, for each of the two layers, the fold separating the middle layerand the inner layer corresponds to the bend in the second segment of thepredetermined shape.

In the first implanted shape, the pinched end can be suspended withinthe sacks of layer A and layer B. In the second implanted shape, thepinched end can be encircled by the proximal inversions of layer A andlayer B.

In the first implanted shape, the two layers can form an open end thatencircles the sack. In the second implanted shape, the open end canencircle the fold.

The implant can be configured to treat a first aneurysm can include afirst diameter measuring about 4 mm and a first height measuring about 6mm, a second aneurysm can include a second diameter measuring about 5 mmand a second height measuring about 8 mm, and a third aneurysm caninclude a third diameter measuring about 6 mm and a third heightmeasuring about 6 mm.

The implant can be configured to treat a plurality of aneurysms within acontinuum of aneurysm sizes, the continuum bounded by and includingdiameters between about 4 mm and about 5 mm and heights between about 6mm and about 8 mm.

As an alternative to being implanted two implanted shapes, the twolayers of tubular braid can be stable in an implanted shape based on thepredetermined shape when constrained by a substantially sphericalcavity. In the implanted shape, layer A can include an outer layerapposed to a cavity wall of the substantially spherical cavity, layer Bcan include and outer layer apposed to the outer layer of layer A, layerB can include an inner sack apposed to the outer layer of layer B, andlayer A can include an inner sack positioned within the inner sack oflayer B. Further, for each of the two layers, a proximal inversioncorresponding to the first inversion can be positioned approximate anentrance to the substantially spherical cavity, and a distal inversioncorresponding to the second inversion can be positioned approximate adistal portion of the cavity wall. Further, each of the two layers caninclude a post corresponding to the third segment such that the postsextend centrally within the respective inner sacks and along a majorityof a length between the distal inversion and the proximal inversion. Thepost of layer B can be positioned within the post of layer A.

An example method for treating an aneurysm can include one or more ofthe following steps implemented in a variety of orders and can includeadditional steps as understood by a person of ordinary skill in the artaccording to the teachings of the present disclosure. A distal end of acatheter can be positioned approximate an aneurysm neck of an aneurysm.A pinched end of an implant comprising two layers (a layer A and a layerB) of tubular braid can be pushed distally through at least a portion ofthe catheter. An outer layer of layer A can appose to the aneurysm wall.An outer layer of layer B can appose to the outer layer of layer A. Asack can be formed of layer B, such that the sack is at least partiallysurrounded by the outer layers of layer A and layer B. A sack can beformed of layer A such that the sack is at least partially surrounded bythe outer layers of layer A and layer B and is contained within the sackof layer B. The implant can be positioned within the aneurysm solely viamanipulation of the pinched end and via positioning of the distal end ofthe catheter.

Each of the two layers can be extended to respectively form a singlelayer tubular shape such that layer A is surrounded by layer B. The twolayers can be collapsed to have an outer circumference that is smallerthan the outer circumference of a completely collapsed single layertubular braid having a wire count equal to the sum of the wire count ofthe two layers and a wire circumference about equal to the average wirecircumference of the wires in the two layers.

The outer layer A can press to the aneurysm wall with a radial forcethat is greater than a radial force applied by a single layer braid toan aneurysm wall of a second aneurysm having a substantially identicalsize to the aneurysm, the two layers having a total wire count that isabout equal to the wire count of the single layer braid, an average wirecircumference about equal to the average wire circumference of thesingle layer braid, and a predetermined shape formed by a substantiallyidentical process as the single layer braid.

The implant can be implanted such that, compared to a similarlyimplanted single layer braid, across the aneurysm neck the two layers ofbraid have a smaller inlet channel, a decreased porosity, and/or anincreased metal coverage. In this step, the two layers have a total wirecount that is about equal to the wire count of the single layer braid,an average wire circumference about equal to the average wirecircumference of the single layer braid, and a predetermined shapeformed by a substantially identical process as the single layer braid.Also, in this step, the single layer braid is implanted in an aneurysmhaving a substantially identical size as the aneurysm in which thetwo-layer implant is implanted.

The sacks of each of the two layers can be collapsed to form an innerlayer and a middle layer separated by a fold in each of the two layerssuch that that the inner layer of layer B apposes the inner layer oflayer A which apposes the middle layer of layer A which apposes themiddle layer of layer B which apposes the outer layer of layer B. Thepinched end can be positioned approximate the aneurysm neck. The pinchedend can be disengaged while the pinched end is positioned approximatethe aneurysm neck and the sacks of each of the two layers are collapsed.Alternatively, the pinched end can be disengaged while two layers eachretain their respective sacks.

When the sacks of each of the two layers are collapsible to form theinner layer and the middle layer, the method can further includedetermining the implant is suitable for treating a first aneurysmcomprising a first diameter measuring about 4 mm and a first heightmeasuring about 6 mm, a second aneurysm comprising a second diametermeasuring about 5 mm and a second height measuring about 8 mm, and athird aneurysm comprising a third diameter measuring about 6 mm and athird height measuring about 6 mm. Additionally, or alternatively, themethod can further include determining the implant is suitable fortreating a continuum of aneurysm sizes, the continuum bounded by andincluding diameters between about 4 mm and about 5 mm and heightsbetween about 6 mm and about 8 mm.

As an alternative to collapsing the sacks of each of the two layers, atubular segment of layer A can be extended within the sack of layer Aand the sack of layer B to terminate at the pinched end. A tubularsegment of layer B can be extended within the tubular segment of layer Ato terminate at the pinched end. The pinched end can be positionedapproximate the aneurysm neck. The pinched end can be disengaged whilethe pinched end is positioned approximate the aneurysm neck and thetubular segments extend within the respective sacks.

An example method for forming an implant can include one or more of thefollowing steps implemented in a variety of orders and can includeadditional steps as understood by a person of ordinary skill in the artaccording to the teachings of the present disclosure. Two layers oftubular braid (a layer A and a layer B) constricted at a pinched end canbe shaped to a predetermined shape. Forming the predetermined shape caninclude inverting each of the two layers of tubular braid to form arespective distal inversion and inverting each of the two layers oftubular braid to form a respective proximal inversion, each respectivedistal inversion separating an inner segment and a middle segment ofeach of the two layers, the inner segment of each of the two layersextending from the respective distal inversion to the pinched end and atleast partially surrounded by the middle segment, each respectiveproximal inversion separating the middle segment from an outer segmentof each of the two layers, and each respective middle segment extendingfrom the first inversion to the second inversion and at least partiallysurrounded by the outer segment.

The implant can be determined to be suitable for treating a firstaneurysm comprising a first diameter measuring about 4 mm and a firstheight measuring about 6 mm, a second aneurysm comprising a seconddiameter measuring about 5 mm and a second height measuring about 8 mm,and a third aneurysm comprising a third diameter measuring about 6 mmand a third height measuring about 6 mm.

The implant can be determined to be suitable for treating a continuum ofaneurysm sizes, the continuum bounded by and including diameters betweenabout 4 mm and about 5 mm and heights between about 6 mm and about 8 mm.

An example implant can include a tubular braid having an open end and apinched end. The tubular braid can have a predetermined shape that hastwo inversions that divide the braid into three segments. In thepredetermined shape, the braid can have an outer segment that extendsbetween the open end and a first of the two inversions, a middle segmentthat extends between the two inversions and is encircled by the openend, and an inner segment that extends between the second of the twoinversions and the pinched end of the tubular braid and is surrounded bythe middle segment.

When in the predetermined shape, the tubular braid can have a heightmeasured between the two inversions and a substantially radiallysymmetrical shape having an outermost diameter. The ratio of outermostdiameter to height can be between about 2:1 and about 1:3 or, morespecifically, between about 2:1 and about 1:1. In the predeterminedshape the middle segment can have maximum diameter that is equal to thediameter of the open end. When compressed, the tubular braid can beextended longitudinally to a single layer of braid having a lengthmeasured from the open end to the pinched end. The ratio of theoutermost diameter in the predetermined shape to length in thecompressed, delivery shape can be between about 0.2 and about 0.3.

The length of the tubular braid in the delivery shape can be betweenabout 10 mm an about 40 mm, depending on the size of the aneurysm beingtreated.

A collection of implants, each having a uniquely shaped tubular braidcan be created to provide a catalogue of implants for treating aneurysmsranging in diameter and height. Each implant in the collection can besuitable for treating aneurysms with a sub-range of diameters and a subrange of heights.

The tubular braid can have two distinct implanted shapes based on thepredetermined shape and constrained by the geometry of an aneurysm inwhich the tubular braid is implanted. In other words, the implant can beimplanted in either a larger aneurysm or a smaller aneurysm, the smalleraneurysm having a height measuring less than the height of the largeraneurysm, and the tubular braid can take one of the two implanted shapeswhen implanted in the larger aneurysm and the tubular braid can take onthe other of the implanted shapes when implanted in the smalleraneurysm. In either implanted shape, the first, outer segment of thepredetermined shape can be positioned to form an outer layer thatjuxtaposes/apposes an aneurysm wall and the inversion adjacent to theouter segment in the predetermined shape can be positioned to form aproximal inversion at an aneurysm neck. When implanted in the largeraneurysm, the second, middle segment of the predetermined shape can forma sack that apposes a portion of the aneurysm wall and apposes the outerlayer of the braid, the pinched end can be suspended within the sack ofthe braid, and the open end can encircle the sack. When implanted in thesmaller aneurysm, the middle segment of the predetermined shape can befolded to form a middle layer that apposes the outer layer and an innerlayer that apposes the middle layer, the open end can be positioned nearthe fold dividing the middle and inner layers, and the pinched end canbe positioned near the proximal inversion and aneurysm neck. The tubularbraid in the predetermined shape can have a bend in the middle, secondsegment, and when tubular braid is in the smaller aneurysm implantedshape, the middle segment can fold at the bend to separate the middlelayer from the inner layer.

An example implant having the tubular braid having two distinctimplanted shapes can treat aneurysms within a range of sizes includingan aneurysm having a diameter of 4 mm and a height of 6 mm, an aneurysmhaving a diameter of 5 mm and a height of 8 mm, and an aneurysm having adiameter of 6 mm and a height of 6 mm. Additionally, or alternatively,the implant can be suitable for treating aneurysms within a continuum ofaneurysm sizes, the continuum bounded by and including aneurysmdiameters between 4 mm and 5 mm and heights between 6 mm and 8 mm. Theimplant capable of treating aneurysms having the aforementioned sizes,when compressed for delivery through a microcatheter can have a lengthmeasuring between about 22 mm and about 25 mm.

As an alternative to having two distinct implanted shapes, the implantcan have an implanted shape that includes a compaction resistant postextending within an inner sack of the braid and extending between aproximal inversion near an aneurysm neck and a distal inversion near adistal portion of an aneurysm wall. In the implanted shape, the tubularbraid can have an outer layer that corresponds to the outer segment inthe predetermined shape, the inner sack in the implanted shape cancorrespond to the middle segment in the predetermined shape, thecompaction resistant post can correspond to the inner, third segment inthe predetermined shape, and the distal and proximal inversions cancorrespond to the two inversions in the predetermined shape. Thecompaction resistant post can serve to inhibit the implant fromimpacting when implanted in the aneurysm.

An example method of treating an aneurysm can include one or more of thefollowing steps presented in no particular order, and the method caninclude additional steps not included here. A tubular braid having anopen end and a pinched end can be selected and shaped to a predeterminedshape. The predetermined shape can be formed by inverting the braid toform a distal inversion, moving the open end over some or all of thebraid to form a proximal inversion, shaping a first segment that extendsbetween the open end and the proximal inversion, shaping a secondsegment that extends between the two inversions, positioning the openend to encircle the second segment, shaping a third segment that extendsbetween the distal inversion and the pinched end of the braid, andpositioning the second segment to surround the third segment. Formingthe predetermined shape can further include shaping the open end andsecond segment so that the open end has a diameter greater than or equalto the maximum diameter of the second segment.

The tubular braid can be formed in the predetermined shape such that thetubular braid is implantable in two distinct implanted shapes and ineither of two aneurysms having differing heights such that the braidtakes on one implanted shape in the taller aneurysm and the second,different implanted shape in the shorter aneurysm. The example methodcan further include reshaping the tubular braid into one of the twodistinct implanted shapes. When the tubular braid is reshaped for thetaller aneurysm, the first segment can be reshaped to form an outerbraid layer that apposes an aneurysm wall of the taller aneurysm, theproximal inversion can be positioned at the neck of the taller aneurysm,and the second segment can be reshaped to form a sack that nests withinthe outer layer and also apposes the aneurysm wall of the talleraneurysm. When the tubular braid is reshaped for the shorter aneurysm,the first segment can be reshaped to form an outer braid layer thatapposes an aneurysm wall of the shorter aneurysm, the proximal inversioncan be positioned at the neck of the shorter aneurysm, and the secondsegment can be folded to form a middle braid layer that apposes theouter layer and an inner braid layer that apposes the middle layer.

Forming the predetermined shape can further include forming a bend inthe second segment, and when the tubular braid is reshaped for theshorter aneurysm, the second segment can be folded at the bend to formthe fold that separates the middle braid layer and the inner braidlayer.

When the tubular braid is reshaped for the taller aneurysm, the pinchedend can be suspended within the sack. When the tubular braid is reshapedfor the smaller aneurysm, the pinched end can be positioned near theproximal inversion.

When the tubular braid is reshaped for the taller aneurysm, the open endcan encircle the sack. When the tubular braid is reshaped for theshorter aneurysm, the open end can be positioned near the foldseparating the middle braid layer and the inner braid layer.

The method can further include shaping the tubular braid into a deliveryshape to be delivered through a microcatheter. The tubular braid canhave a length in the delivery shape that is measured between the openend and the pinched end. When the tubular braid is shaped to thepredetermined shape, it can be shaped to have an outermost diameter. Thelength of the tubular braid in the delivery shape can measure between3.5 and 5 times that of the outermost diameter of the tubular braid inthe predetermined shape.

In the predetermined shape, the outermost diameter can be shaped to bebetween 2 and ⅓ times the height of the tubular braid.

When the tubular braid is shaped to the predetermined shape, the tubularbraid can be shaped to be suitable to be implanted in an aneurysm havinga diameter of 4 mm and a height of 6 mm, an aneurysm having a diameterof 5 mm and a height of 8 mm, and an aneurysm having a diameter of 6 mmand a height of 6 mm. Additionally, or alternatively, when the tubularbraid is shaped to the predetermined shape, the tubular braid can beshaped to be suitable for treating a continuum of aneurysm sizesincluding aneurysms having diameters between 4 mm and 5 mm and heightsbetween 6 mm and 8 mm. The tubular braid that is suitable for treatinganeurysms sized as above can be extended to a single layer deliveryshape having a length measuring between about 22 mm and about 25 mm, thedelivery shape sized to be delivered through a microcatheter.

The method can further include positioning the proximal inversion on aproximal side of a plane defining a boundary between an aneurysm andblood vessel branches. The first segment can be reshaped to appose ananeurysm wall and the second segment can be reshaped to provide anoutwardly radial force in the plane. The force can be sufficient toappose the first segment to the aneurysm neck. The force can also besufficient to resist compaction of the implant within the aneurysm.

The method can further include collapsing the implant to fit within amicrocatheter and pushing the pinched end of the unsheathed tubularbraid through a majority of the length of the microcatheter to ananeurysm within a patient.

An example tubular implant including an open end and a pinched end canhave a predetermined shape. When in the predetermined shape, the tubularbraid can include a proximal inversion and two segments, and the braidcan be composed of one or more wires. The first segment can extend fromthe open end of the tubular braid to the proximal inversion. The secondsegment can be at least partially surrounded by the open end and extendfrom the proximal inversion to the pinched end. The tubular braid canalso include at least one corrugated fold. The one or more corrugatedfolds can be located within the first segment, second segment, or both.The corrugated folds can be configured to assist in anchoring theexample device when in the implanted shape within an aneurysm in asimilar manner to stent struts to help the tubular braid hold its shape.

In an example, the tubular braid can be formed into the predeterminedshape by inverting the braid inwardly to separate the second segmentfrom the first segment. The tubular braid can include memory shapematerial that can be heat set to a predetermined shape. This heat-setmaterial can be utilized to form corrugations in the first or secondsegments, or both. Further, the wires of the tubular braid making up thecorrugated folds of the first segment can be compressed or flattenedalong a vertical axis. Flattening the wires of the corrugated folds canmake these portions of the tubular braid more rigid, thereby assistingin maintaining the shape of the tubular braid and anchoring it within ananeurysm. Flattening wires within the braid can make those wiresbendable in two opposite directions rather than in all directions, whichmakes the flattened or compressed wires more resistant to bending thanother non-flattened wires in the braid. When the tubular braid is in thepredetermined shape, at least one corrugated fold in the second segmentcan appose the first segment, can appose a corrugated fold in the firstsegment, or both, thereby exerting an outwardly radial force on thefirst segment.

When in the implanted shape, the braid can have an outer layercorresponding to the first segment of the predetermined shape, aproximal inversion corresponding the proximal inversion of thepredetermined shape, and an inner layer corresponding to the secondsegment of the predetermined shape. The tubular braid can have at leastone corrugated fold in the inner layer, outer layer, or bothcorresponding to the corrugated folds in the predetermined shape. In theimplanted shape, at least one corrugated fold in the inner layer canappose at least a portion of the outer layer, can appose a corrugatedfold in the outer layer, or both, thereby exerting an outwardly radialforce on the outer layer to anchor the implant within the aneurysm. Thecorrugated folds of the outer layer can also provide an outwardly radialforce sufficient to appose the outer layer to the aneurysm wall andanchor the implant within the aneurysm. The corrugated folds in theouter layer can be flattened to increase the rigidity of thecorrugations and assist with anchoring the tubular braid within theaneurysm.

An example method for forming an implant to treat an aneurysm caninclude positioning a distal end of a catheter approximate an aneurysmneck, pushing a pinched end of a tubular braid composed of one or morewires and having an open end distally through at least a portion of thecatheter, positioning the open end within an aneurysm sac, and deployingthe tubular braid to an implanted shape within the aneurysm based upon apredetermined shape. The implant in the implanted shape can include aninner layer, outer layer, and proximal inversion. The outer layer, innerlayer, or both can include at least one corrugated fold. At least onecorrugated fold within the inner layer can provide an outwardly radialforce against the outer layer, against a corrugated fold in the outerlayer, or both, the force sufficient to appose the outer layer to theaneurysm wall. In a similar manner, the corrugated folds of the outerlayer can provide an outwardly radial force sufficient to appose theouter layer the aneurysm wall.

The one or more wires in at least one corrugated fold of the tubularbraid can be compressed along a vertical axis such that the diameter ofthe wires of the corrugated fold along the axis is lesser than thediameter of the uncompressed portions of the tubular braid. Thiscompression can increase the rigidity of the at least one corrugatedfold relative to the rest of the braid. The cross-sectional shape of aflattened portion of wire can be different from the cross-sectionalshape of a non-flattened portion.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and further aspects of this invention are further discussedwith reference to the following description in conjunction with theaccompanying drawings, in which like numerals indicate like structuralelements and features in various figures. The drawings are notnecessarily to scale, emphasis instead being placed upon illustratingprinciples of the invention. The figures depict one or moreimplementations of the inventive devices, by way of example only, not byway of limitation.

FIG. 1A is an illustration of an example implant having a tubular braidin a predetermined shape according to aspects of the present invention;

FIG. 1B is an illustration of the example implant with the tubular braidin a first implanted shape according to aspects of the presentinvention;

FIG. 1C is an illustration of the example implant with the tubular braidin a second implanted shape according to aspects of the presentinvention;

FIGS. 2A through 2H are illustrations of an implant having a tubularbraid that expands to a predetermined shape similar to as illustrated inFIG. 1A as the tubular braid exits a microcatheter according to aspectsof the present invention;

FIGS. 3A through 3H are illustrations of the implant showing the tubularbraid expanding to a first implanted shape and a second implanted shapewithin an aneurysm according to aspects of the present invention;

FIG. 4A is an illustration of the implant showing the tubular braidexpanded in the first implanted shape in a tube having a 5 mm diameteraccording to aspects of the present invention;

FIG. 4B is an illustration of the implant showing the tubular braidexpanded in the second implanted shape in a tube having a 4 mm diameteraccording to aspects of the present invention;

FIGS. 5A through 5D are illustrations of the example implant asillustrated in FIGS. 1A through 1C implanted in either the firstimplanted shape or the second implanted shape in aneurysms ranging insize according to aspects of the present invention;

FIGS. 6A and 6B are illustrations of measurements of an example implantand an aneurysm according to aspects of the present invention;

FIG. 7A is an illustration of an example implant having a tubular braidin an alternative predetermined shape according to aspects of thepresent invention;

FIG. 7B is an illustration of the example implant illustrated in FIG. 7Awith the tubular braid in an implanted shape according to aspects of thepresent invention;

FIG. 8A is an illustration of an example implant having a tubular braidin another alternative predetermined shape according to aspects of thepresent invention;

FIG. 8B is an illustration of the example implant illustrated in FIG. 8Awith the tubular braid in an implanted shape according to aspects of thepresent invention;

FIG. 9A is an illustration of an example implant having a tubular braidin another alternative predetermined shape according to aspects of thepresent invention;

FIG. 9B is an illustration of the example implant illustrated in FIG. 9Awith the tubular braid in an implanted shape according to aspects of thepresent invention;

FIG. 10 is an illustration of an implant having a tubular braid in apredetermined shape similar to as illustrated in FIG. 9A according toaspects of the present invention;

FIGS. 11A through 11E are illustrations of the implant illustrated inFIG. 10 showing the tubular braid expanding to the implanted shapesimilar to as illustrated in FIG. 9B according to aspects of the presentinvention;

FIG. 12A is an illustration of an example implant having two layers oftubular braid in a predetermined shape according to aspects of thepresent invention;

FIG. 12B is an illustration of the example implant of FIG. 12A in acatheter for delivery according to aspects of the present invention;

FIG. 12C is an illustration of the example implant of FIGS. 12A and 12Bwith the two layers of tubular braid in a first implanted shapeaccording to aspects of the present invention;

FIG. 12D is an illustration of the example implant of FIGS. 12A through12C with the two layers of tubular braid in a second implanted shapeaccording to aspects of the present invention;

FIG. 13 is an illustration of an example implant having two layers oftubular braid in a predetermined shape similar to that of FIG. 12A andhaving an alternative braid configuration according to aspects of thepresent invention; and

FIG. 14 is an illustration of an example implant having two layers oftubular braid in an alternative predetermined shape according to aspectsof the present invention.

FIGS. 15A to 15C illustrate example implants with one or more corrugatedfolds in a predetermined shape according to aspects of the presentinvention;

FIGS. 16A and 16B illustrate example implants with one or morecorrugated folds in an implanted shape according to aspects of thepresent invention; and

FIG. 16C illustrates a cross sectional view of a compressed corrugatedfold according to aspects of the present invention.

DETAILED DESCRIPTION

Examples presented herein generally include a braided implant that cansecure within an aneurysm sac and occlude a majority of the aneurysm'sneck. The implant can include a tubular braid that can be set into apredetermined shape, compressed for delivery through a microcatheter,and implanted in at least one implanted position that is based on thepredetermined shape and the geometry of the aneurysm in which the braidis implanted. When compressed, the implant can be sufficiently short tomitigate friction forces produced when the implant is deliveredunsheathed through the microcatheter allowing for a more simplisticdelivery system compared to some other known braided embolic implantdelivery systems

FIGS. 1A through 1C are illustrations of an example braided implant 100that can have a predetermined shape as illustrated in FIG. 1A and twodistinct implanted shapes as illustrated in FIGS. 1B and 1C. The implant100 can treat a range of aneurysm sizes including a larger aneurysm 10 aas illustrated in FIG. 1B and a smaller aneurysm 10 b as illustrated inFIG. 1C. The implant 100 can have a first implanted shape (FIG. 1B) thatcan be conducive for treating larger aneurysms 10 a and a secondimplanted shape (FIG. 1C) that can be conducive for treating smalleraneurysms 10 b. The implant 100 can include a tubular braid 110 havingan open end 114 and a pinched end 112. The implant 100 can include adetachment feature 150 attached to the braid 110 at the pinched end 112.The tubular braid 110 can be formed in the predetermined shape (FIG.1A), collapsed for delivery through a microcatheter, attached to adelivery system at the detachment feature 150, and implanted in a shapesimilar to one or the other of the two implanted shapes (FIG. 1B or FIG.1C).

Referring to FIG. 1A, when in the predetermined shape, the tubular braid110 can include two inversions 122, 124, dividing the braid 110 intothree segments 142, 144, 146. In the predetermined shape, the braid 110can have an outer segment 142 extending from the open end 114 of thebraid 110 to one of the inversions 122, an inner segment 146 extendingfrom the pinched end 112 of the braid 110 to the other of the inversions124, and a middle segment 144 extending between the two inversions 122,124. When in the predetermined shape, the tubular braid 110 can besubstantially radially symmetrical about a central vertical axis y (seeFIG. 6A). FIG. 1A illustrates a profile of each segment 142, 144, 146,and the detachment feature 150 is illustrated as a flat key that can beused with a mechanical implant delivery system (not illustrated).

The tubular braid 110 can be formed into the predetermined shape byfirst inverting the braid outwardly to separate the inner segment 146from the middle segment 144 with an inversion 124, then the middlesegment 144 can be shaped over a form to produce the substantially “S”shaped profile illustrated, and finally, the braid 110 can be invertedoutwardly again to separate the middle segment 144 from the outersegment 142 with another inversion 122. If necessary, the braid can betrimmed at the open end 114. The open end 114 can be positioned toencircle the middle segment 144. The open end 114 can positioned withinthe middle third section of the braid's height as illustrated.

It can be advantageous to minimize a neck opening 126 defined by thelower extension of the “S” shape of the middle segment 144 to maximizeocclusion of an aneurysm neck when the implant 100 is implanted. Themiddle segment 144 can have one or more bends 132, 134. The bends 132,134 can be positioned facilitate the movement of the braid 110 into thesecond implanted shape illustrated in FIG. 1C and the bends 132, 134 canbe positioned to stabilize the braid 110 in the first and/or secondimplanted shape.

The tubular braid 110 can include memory shape material that can be heatset to a predetermined shape, can be deformed for delivery through acatheter, and can self-expand to an implanted shape that is based on thepredetermined shape and confined by the anatomy of the aneurysm in whichit is implanted.

As illustrated in FIG. 1B, when in the first implanted shape, the braid110 can have an outer layer 142 a contacting the aneurysm's wall 14 a, asack 144 a nested within the outer layer 142 a, a proximal inversion 122a positioned at the aneurysm's neck 16 a, and a distal inversion 124 apositioned near a distal portion 15 a of the aneurysm wall 14 a. In thefirst implanted shape, the detachment feature 150 and pinched end 112 ofthe braid 110 can be suspended within the sack 144 a.

As illustrated in FIGS. 1A and 1B, the tubular braid 110 in the firstimplanted shape can be radially compressed and vertically extendedcompared to the predetermined shape. The outer layer 142 a in the firstimplanted shape can correspond to the outer layer 142 in thepredetermined shape, the proximal inversion 122 a in the first implantedshape can correspond to the inversion 122 adjacent to the outer layer142 in the predetermined shape, the sack 144 a in the first implantedshape can correspond to the middle segment 144 in the predeterminedshape, the distal inversion 124 a in the first implanted shape cancorrespond to the inversion 124 adjacent to the inner segment 146 in thepredetermined shape, and an inner braid segment 146 a suspending thedetachment feature 150 in the first implanted shape can correspond tothe inner segment 146 in the predetermined shape. In the first implantedshape, the sack 144 a can have a neck opening 126 a corresponding to theneck opening 126 in the predetermined shape.

As illustrated in FIG. 1C, when in the second implanted shape, the braid110 can have an outer layer 142 b contacting the aneurysm's wall 14 b, aproximal inversion 122 b positioned at the aneurysm's neck 16 b, amiddle layer 144 b extending within the outer layer 142 b and pressingagainst the outer layer 142 b, a distal inversion 124 b positioned nearthe open end 114 of the braid 110, and an inner layer 146 b extendingwithin the middle layer 144 b and pressing against the middle layer 144b. In the second implanted shape, the detachment feature 150 and pinchedend 112 of the braid 110 can be positioned at the aneurysm neck 16 b,near the proximal inversion 122 b.

As illustrated in FIGS. 1A and 1C, the tubular braid 110 in the secondimplanted shape can be radially compressed compared to the predeterminedshape, and the middle segment 144 of the predetermined shape can befolded so that the height of the tubular braid 110 is compressed in thesecond implanted shape compared to the predetermined shape.Alternatively, when implanted in the second implanted shape in aneurysmshaving a diameter that is significantly smaller than the aneurysm'sheight, the second implanted shape can be radially compressed comparedto the predetermined shape and the height of the braid in the secondimplanted shape can be greater than the height of the braid in thepredetermined shape.

The outer layer 142 b in the second implanted shape can correspond tothe outer layer 142 in the predetermined shape, the proximal inversion122 b in the second implanted shape can correspond to the inversion 122adjacent to the outer layer 142 in the predetermined shape, the middlelayer 144 b and inner layer 146 b in the second implanted shape cancorrespond to the middle segment 144 in the predetermined shape, thedistal inversion 124 b in the second implanted shape can correspond to abend 134 in the middle segment 144 in the predetermined shape, and aportion of the braid 110 near the detachment feature 150 forming theinner layer 146 b in the second implanted shape can correspond to theinner segment 146 in the predetermined shape.

FIGS. 2A through 2H are illustrations of an example implant 100 having abraid 110 expanding to a predetermined shape as the braid 110 exits amicrocatheter 600. The implant 100 has a predetermined shape similar toas illustrated in FIG. 1A. As illustrated in FIG. 2A, the braid 110 canbe shaped to a delivery shape that is extended to a single layer oftubular braid having a compressed circumference/diameter sized to bedelivered through the microcatheter 600 and a length L. The illustratedimplant 100 has a length L of between about 22 mm and about 25 mm. Aswill be appreciated and understood by a person of ordinary skill in theart, the length L of a specific braid 110 can be tailored based on thesize and shape of the aneurysm being treated.

During delivery through the microcatheter 600, the detachment feature150 can be attached to a delivery system at a proximal end of theimplant 100, the pinched end 112 can be positioned near the proximal endof the implant 100, and the open end 114 can define the distal end ofthe implant 100. Collapsing the braid 110 to a single layer tube canresult in a braid 110 that has a sufficiently small diameter and asufficiently short length L to mitigate effects of friction force on thebraid 110 when it is delivered through the microcatheter, allowing thebraid 110 to be delivered unsheathed in some applications.

As illustrated in FIG. 2B, the open end 114 can be positioned to exitthe microcatheter 600 before any other portion of the braid 110 exitsthe microcatheter. The open end 114 can expand as it exits themicrocatheter 600. If the open end 114 is unconstrained by an aneurysmas illustrated, the open end can expand to its circumference in thepredetermined shape.

As illustrated in FIG. 2C, the distal portion of the braid 110 cancontinue to expand radially as it exits the microcatheter 600.

As illustrated in FIG. 2D, the braid 110 can form the inversion 122defining the outer segment 142 as the braid 110 is further pushed out ofthe microcatheter 600.

As illustrated in FIGS. 2E through 2G, the “S” shape of the middlesegment 144 can begin to form as the braid 110 is further pushed fromthe microcatheter 600.

As illustrated in FIG. 2H, when all, or nearly all of the braid 110exits the microcatheter 600, the braid 110, not confined by an aneurysm,can expand to a predetermined shape similar to the shape illustrated inFIG. 1A. In the predetermined shape, the braid 110 of the illustratedimplant has a diameter between about 6 mm and about 6.5 mm and a heightbetween about 5 mm and about 5.5 mm.

The ratio of the outermost diameter of the braid 110 in thepredetermined shape illustrated in FIG. 2H to the length of the braid110 in the delivery shape illustrated in FIG. 2A is between about 0.3and about 0.24.

FIGS. 3A through 3H are illustrations of the implant 100 illustrated inFIGS. 2A through 2H expanding within an aneurysm 10 in two differentimplanted shapes. The aneurysm 10 has a height of about 6 mm, a diameterof about 6 mm, and a neck diameter of about 4 mm. Comparing thedimensions of the aneurysm 10 to the braid 110 in the predeterminedshape illustrated in FIG. 2H, the braid 110 has a slightly largerdiameter and a slightly smaller height, and the interior of the aneurysm10 is substantially spherical while the outer dimensions of the braid110 are more cylindrical (see FIGS. 6A and 6B for measurementorientation). When the braid 110 of the implant 100 is confined by theaneurysm 10, the braid 110 is therefore be radially constrained.

As illustrated in FIG. 3A, the implant 100 can be delivered to theaneurysm 10 through the microcatheter 600, as described in relation toFIG. 2A. The open end 114 of the tubular braid 110 can expand within theaneurysm 10 as it exits the microcatheter 600. The illustrated aneurysm10 is positioned at a bifurcation including a stem blood vessel 20 andtwo branch vessels 22 a, 22 b, and the microcatheter 600 is illustratedbeing delivered through the stem blood vessel 20. It is contemplatedthat the implant could be delivered to an aneurysm on a sidewall of ablood vessel through a curved microcatheter, and such a procedure isintended to be embraced by the scope of the present disclosure.

As illustrated in FIG. 3B, as the braid 110 is further pushed distallyfrom the microcatheter 600, the braid 110 can expand to appose theaneurysm wall 14 and conform to the aneurysm neck 16. The aneurysm 10being treated can have a diameter that is less than the outer diameterof the tubular braid 110 in the predetermined shape so that the braid110 tends to expand outwardly, providing a force against the aneurysmwall 14, and sealing around the perimeter of the aneurysm neck 16. Theimplant 100 can be particularly suitable for treating a wide neckaneurysm such as commonly occur at bifurcations because the radial forceprovided by the braid 110 against the aneurysm wall 14 and perimeter ofthe neck 16 can be sufficient to both anchor the implant 100 in a wideneck aneurysm and seal the neck 16 of the aneurysm 10.

As illustrated in FIG. 3C, as the braid 110 is further pushed distallyfrom the microcatheter 600, the proximal inversion 122 a can be formed.

As illustrated in FIG. 3D, the microcatheter 600 can be manipulated toplace the proximal inversion 122 a at the aneurysm neck 16. The proximalinversion 122 a can be placed on a proximal side of a plane defining aboundary 18 (See FIG. 6B) between the aneurysm 10 and the branch vessels22 a, 22 b. In some applications it can be advantageous to place theproximal inversion 122 a far enough in the proximal direction from theplane 18 so that the outer layer 142 a of the braid 110 seals around theouter perimeter of the aneurysm neck 16, but not so far proximally thatthe implant 100 becomes an obstruction to the blood vessels 22 a, 22 b,20.

As illustrated in FIG. 3E, the braid 110 can expand within the aneurysmsac 12 and extend to appose an inner surface of the outer layer 142 a ofthe braid 110. The apposition to the outer layer 142 a can provideadditional force to anchor the outer layer 142 a to the aneurysm wall14.

As illustrated in FIG. 3F, the aneurysm 10 has a height that canaccommodate the tubular braid 110 in the first implanted shape similarto that illustrated in FIG. 1B. Because the braid 110 is radiallyconstrained and has a more cylindrical shape compared to thesubstantially spherical shape of the aneurysm, the braid 110 can extendbeyond the height of the predetermined shape to accommodate aneurysmstaller than the predetermined shape. In the illustration, the tubularbraid 110 of the implant 100 in the predetermined shape has a heightbetween about 0.5 mm and 1 mm less than the height of the aneurysm, orin other words, the implant has extended between about 10% and about 20%in height in the first implanted shape compared to the predeterminedshape.

The braid can be pulled proximally as illustrated in FIG. 3G to form asecond implanted shape as illustrated in FIG. 3H that is similar to thesecond implanted shape illustrated in FIG. 1C, but different in that theaneurysm 10 b illustrated in FIG. 1C is smaller (proportionally comparedto the braid 110) than the mock aneurysm 10 illustrated in FIG. 3H.Before the implant 100 is released from the delivery system, the implant100 can be partially or fully retracted into the microcatheter 600 andrepositioned in either of the first implanted shape or the secondimplanted shape. Additionally, or alternatively, the microcatheter 600can be moved distally to move the braid 110 from the second implantedshape illustrated in FIG. 3H to the first implanted shape illustrated inFIG. 3F. In some applications, while positioning the implant 100, aphysician can choose whether the first implanted shape or the secondimplanted shape is more suitable for the anatomy of the aneurysm andtreatment site. For treatments involving aneurysms and implants shapedsimilar to the aneurysm 10 and implant 100 illustrated in FIGS. 3Athrough 3H, it can be more advantageous to shape the braid 110 in thefirst implanted shape as illustrated in FIG. 3F (rather than the secondimplanted shape illustrated in FIG. 3G) because the first implantedshape in this example implementation provides a larger surface area ofthe braid 110 in contact with the aneurysm wall 14.

FIGS. 4A and 4B are illustrations of the braid 110 of the exampleimplant illustrated in FIGS. 2A through 2H and 3A through 3H showing thetubular braid 110 expanded within tubes to determine a range of aneurysmdiameters and aneurysm heights that an implant 100 having the dimensionsof the example implant 100 would be suitable for treating. FIG. 4Aillustrates the braid 110 in a tube having a 5 mm diameter. The braid110 is in the first implanted shape and has a height of about 8 mm. Thebraid 110 is therefore radially constrained from its predetermined shapeby between about 1 mm and 1.5 mm in diameter, or between about 17% and23%, and expanded vertically in height by between about 2.5 mm and 3 mm,or between about 45% and 60%.

FIG. 4B illustrates the braid 110 in a tube having a 4 mm diameter. Thebraid 110 is in the second implanted shape and has a height of about 6mm. The braid is therefore radially constrained from its predeterminedshape by between about 2 mm and 2.5 mm in diameter, or between about 33%and 38%, and expanded vertically between about 0.5 mm and 1 mm, orbetween about 10% and 20%.

Implants having a predetermined shape and dimensions as illustrated anddescribed in relation to FIG. 2H can therefore be suitable for treatinganeurysms having a diameter between and including about 4 mm and about 5mm and a height between and including about 6 mm and about 8 mm. Asillustrated in FIG. 3F, the implant can also be suitable for treating ananeurysm having a diameter of 6 mm and a height of 6 mm. As will beappreciated and understood by a person of ordinary skill in the art, thedimensions of the tubular braid in the predetermined shape can betailored to treat aneurysms within a range of sizes not specificallyoutlined herein according to the principles described herein. It iscontemplated that a collection of implants so shaped can be madeavailable to physicians, and a physician can choose a suitable implantfrom the collection based on aneurysm height, diameter, neck diameter,and/or other anatomical features.

A collection of implants, each having a uniquely shaped tubular braidcan be created to provide a catalogue of implants for treating aneurysmsranging in diameter and height. The catalogue can include implantssuitable for treating aneurysms ranging from 3 mm to 15 mm in diameterand ranging from 3 mm to 15 mm in height, or in another example, rangingfrom 3 to 11 mm in diameter and 3 to 7 mm in height. As will beappreciated and understood by a person of ordinary skill in the art,some aneurysm dimensions are extremely rare, and the catalog need notinclude implants for treating aneurysms having a large height:diameterratio or a large diameter:height ratio.

Each implant in the collection can be suitable for treating aneurysmswith a sub range of diameters and a sub-range of heights. An examplecatalogue can include a listing of implants for treating aneurysms ofone or more of, but not limited to, the following size sub ranges(diameter range in mm, height range in mm): (3-5, 3-5), (6-8, 4-5), and(9-11, 5-7).

In some examples, each size sub range can be treated by a single implanthaving a tubular braid uniquely sized and shaped to be suitable fortreating aneurysms within that sub range. In some examples, the subranges in the catalogue can be represented by implants each having atubular braid with a delivery length (length when the braid is collapsedfor delivery through a microcatheter) that is about 10 mm, about 40 mm,and/or including a length in between.

As will be appreciated and understood by a person of ordinary skill inthe art, aneurysm height and diameter are measured with some margin oferror. To that end, the size sub range included in the catalogue for agiven implant can represent a portion of aneurysm sizes that can betreated with the implant and the implant can treat aneurysms outside ofthe listed sub range. For instance, an implant listed for treatinganeurysms having heights between height a and height b and diameterrange between diameter x and diameter y can be suitable for treatinganeurysms slightly taller than the maximum listed height b if thediameter of the aneurysm is near the lower limit of the range (aboutdiameter x), the implant can be suitable for treating diameters slightlylarger than diameter y if the height of the aneurysm is near the lowerlimit of the height range (about height a).

FIGS. 5A through 5D are illustrations of the example implant 100 asillustrated in FIGS. 1A through 1C implanted in either the firstimplanted shape or the second implanted shape in aneurysms ranging insize. FIG. 5A illustrates a large aneurysm 10 a, FIGS. 5B and 5Cillustrate a medium aneurysm 10 c, and FIG. 5D illustrates a smallaneurysm 10 b. The implant 100 is advantageously implanted in ananeurysm 10 a, 10 b, 10 c having a diameter about equal to or smallerthan the diameter of the braid 110 in the predetermined shape so thatthe braid 110 provides an outward force F against the aneurysm wall 14when implanted. The braid 110 can have inner layers that press againstone or more outer layers, contributing to the force F.

As illustrated in FIG. 5A, the maximum size of an aneurysm 10 a that theimplant 100 can be suitable for treating can be determined by thedimensions that the braid 110 can take in the first implanted shape. Thepinched end 112 and detachment feature 150 can be positioned near adistal portion 15 a of the aneurysm wall 14 a as similarly illustratedin FIG. 1B.

As illustrated in FIG. 5B, the implant 100 can also be suitable fortreating a medium sized aneurysm 10 c that is smaller than the aneurysm10 a illustrated in FIG. 5A in the first implanted shape. To fit withinthe medium aneurysm 10 c in the first implanted shape, the pinched end112 and detachment feature 150 can be positioned away from the distalportion 15 c of the aneurysm wall compared to the position of thepinched end 112 and detachment feature 150 in the large aneurysm 10 a.In the predetermined shape (see FIG. 1A), the middle segment 144 caninclude a bend 134 to stabilize the tubular braid 110 in the firstimplanted shape in the medium aneurysm 10 c as illustrated in FIG. 5B.

As illustrated in FIG. 5C, the implant 100 can also be suitable fortreating the medium sized aneurysm 10 c in the second implanted shape.The middle segment 144 of the braid in the predetermined shape (see FIG.1A) can be folded to form a middle layer 144 b and an inner layer 146 bsimilar to as described in relation to FIG. 1C. In some applications,either implanted shape could be effective for treating the aneurysm 10c, and a physician can select a preferred shape during treatment. Forinstance, a physician can decide to use the first implanted shape (FIG.5B) to elongate the implant so that the proximal fold 122 a can beplaced proximally outside of the aneurysm neck, or the physician candecide to use the second implanted shape (FIG. 5C) to provide morelayers of braid at the aneurysm neck to occlude the neck opening 16 c.

As illustrated in FIG. 5D, the minimum size of aneurysm 10 b that theimplant 100 can be suitable for treating can be determined by thedimensions that the braid 110 can take in the second implanted shape.The open end 114 and/or the distal fold 124 b can be collapsed near adistal portion 15 b of the aneurysm wall in the second implanted shape.

FIG. 6A is an illustration of height HI and diameter D1, D2 measurementsof an example implant 100 in a predetermined shape. In the predeterminedshape, the braid 110 of the example implant 100 can be substantiallyradially symmetrical about vertical axis y, and therefore can havesubstantially circular concentric cross-sections each describable by itsdiameter. FIG. 6A highlights the height HI of the implant 100 in apredetermined shape measured between the inversions 122, 124, the outerdiameter D1 of the outer segment 142, which corresponds to the diameterof the open end 114, and the outer diameter D2 of the middle segment D2.Although FIG. 6A illustrates only one example predetermined shape, itshould be understood that the height and diameter of example implantsdescribed herein 100, 200, 300, 400 and portions thereof can be measuredsimilarly to as illustrated in FIG. 6A.

FIG. 6B is an illustration of height HA, sac diameter DA, and neckdiameter DN measurements of an aneurysm 10. The location of the plane 18defining a boundary between the aneurysm 10 and blood vessels is alsoillustrated.

FIG. 7A is an illustration of an example implant 200 having a tubularbraid 210 in an alternative predetermined shape. FIG. 7B is anillustration of the example implant 200 in an aneurysm 10 with thetubular braid 210 in an implanted shape. The tubular braid 210 can havean open end 214 and a pinched end 212. The implant 200 can include adetachment feature 150 attached to the braid 210 at the pinched end 212.The braid 210 can be formed in the predetermined shape, collapsed fordelivery through a microcatheter, attached to a delivery system at thedetachment feature 150, and implanted in the implanted shape.

As illustrated in FIG. 7A, when in the predetermined shape, the tubularbraid 210 can include two inversions 222, 224, dividing the braid 210into three segments 242, 244, 248. In the predetermined shape, the braid210 can have an outer segment 242 extending from the open end 214 of thebraid 210 to one of the inversions 222, an inner segment 248 extendingfrom the pinched end 212 of the braid 210 to the other of the inversions224, and a middle segment 244 extending between the two inversions 222,224. When in the predetermined shape, the tubular braid 210 can besubstantially radially symmetrical about a central vertical axis y (seeFIG. 6A). FIG. 7A illustrates a profile of each segment 242, 244, 248.

Comparing the predetermined shape of the braid 210 illustrated in FIG.7A to that of the braid 110 illustrated in FIG. 1A, the outer segments142, 242 and middle segments 144, 244 are respectively similar to eachother, and the inner segment 248 of the braid 210 illustrated in FIG. 7Ais longer than the inner segment 146 of the braid 110 illustrated inFIG. 1A. The pinched end 212 of the braid 210 in FIG. 7A is positionednear the inversion 222 adjacent the outer segment 242 rather than nearthe inversion 124 near the inner segment 146 as illustrated in FIG. 1A.The elongated inner segment 248 illustrated in FIG. 7A can be positionedto help the implant 200 resist compaction when implanted as illustratedin FIG. 7B.

The tubular braid 210 illustrated in FIG. 7A can be formed into thepredetermined shape similar to as described in relation to FIG. 1A withsome differences. The middle segment 244 need not have bends 132, 134positioned facilitate the movement of the braid 210 into a secondimplanted shape. The inner segment 248 as illustrated in FIG. 7A can bemade longer than that illustrated in FIG. 1A. The inner segment 248 canbe shaped to have a length that is optimized to reduce the likelihoodthat the implant 200 can become compacted when implanted.

An implant 200 having a braid 210 having a predetermined shape asillustrated in FIG. 7A can have outer dimensions in the predeterminedshape including an outer diameter and height similar to as illustratedand described in relation to FIG. 2H. The inner segment 248 of the braid210 illustrated in FIG. 7A can have a height that is approximately equalto the height of the braid 210 in the predetermined shape.

The braid 210 can be elongated to a single layer tubular braid in adelivery shape that is sized to traverse a microcatheter. The length ofthe braid 210 in the delivery shape can be measured from the open end214 to the pinched end 212. A braid 210 having a predetermined shape asillustrated in FIG. 7A and outer dimensions as illustrated and describedin relation to FIG. 2H can have a length in the delivery shape that islonger compared to the length of the braid 110 illustrated in FIG. 2A.The length of the braid 210 illustrated in FIG. 7A when in the deliveryshape can be longer than a braid 110 having a predetermined shape asillustrated in FIG. 1A by about the height of the braid 110, 210 in thepredetermined shape. In other words, an implant 200 having a braid 210with a predetermined shape as illustrated in FIG. 7A can have an outerdiameter between about 6 mm and about 6.5 mm and a height between about5 mm and 5.5 mm when in the predetermined shape and can be elongated toa single layer tube having a circumference collapsed to fit within amicrocatheter and a length measuring between about 27 mm and 30 mm. Theratio of outermost diameter in the predetermined shape to length in thedelivery shape can be between about 0.24 and about 0.2.

As illustrated in FIG. 7B, when in the implanted shape, the braid 210can have an outer layer 242 a contacting the aneurysm's wall 14, a sack244 a nested within the outer layer 242 a, a proximal inversion 222 apositioned at the aneurysm's neck 16, and a distal inversion 224 apositioned near a distal portion 15 of the aneurysm wall 14. Thedetachment feature 150 and pinched end 212 of the braid 210 can bepositioned near the aneurysm neck 16, near the proximal inversion 222 a.The detachment feature 150 and pinched end 212 can be positioned toreduce the likelihood that the implant 200 becomes impacted.

FIG. 8A is an illustration of an example implant 300 having a tubularbraid 310 in another alternative predetermined shape. FIG. 8B is anillustration of the example implant 300 when the tubular braid 310 in animplanted shape. The tubular braid 310 can have an open end 314 and apinched end 312, and a detachment feature 150 can be attached to thebraid 310 at the pinched end 312. The braid 310 can be formed in thepredetermined shape, collapsed for delivery through a microcatheter,attached to a delivery system at the detachment feature 150, andimplanted in the implanted shape.

As illustrated in FIG. 8A, when in the predetermined shape, the tubularbraid 310 can include two inversions 322, 324, dividing the braid 310into three segments 342, 344, 346. In the predetermined shape, the braid310 can have an outer segment 342 extending from the open end 314 of thebraid 310 to one of the inversions 322, an inner segment 346 extendingfrom the pinched end 312 of the braid 310 to the other of the inversions324, and a middle segment 344 extending between the two inversions 322,324. When in the predetermined shape, the tubular braid 310 can besubstantially radially symmetrical about a central vertical axis. FIG.8A illustrates a profile of each segment 342, 344, 346.

Comparing the predetermined shape of the braid 310 illustrated in FIG.8A to that of the braid 110 illustrated in FIG. 1A, the outer segments142, 342 and inner segments 146, 346 are respectively similar to eachother, and the middle segment 344 of the braid 310 illustrated in FIG.8A has an undulating pattern rather than the “S” shape of the middlesegment 144 of the braid 110 illustrated in FIG. 1A. The undulatingmiddle segment 344 can be radially symmetrical to form a honeycombshape. When implanted, the middle segment 344 in the undulating patterncan provide a force pattern pressing outwardly to anchor the implant 300within an aneurysm that is different from a force pattern that could beprovided by the middle segment 144 having the “S” shape illustrated inFIG. 1A. The pinched end 312 of the braid 310 in FIG. 8A can bepositioned near the inversion 324 adjacent the inner segment 346 asillustrated. Alternatively, the inner segment 346 can be shaped toextend to the inversion 322 adjacent the outer segment 342 to provide acompaction resistant column.

The tubular braid 310 illustrated in FIG. 8A can be formed into thepredetermined shape similar to as described in relation to FIG. 1A withsome differences. The middle segment 344 can be formed to have anundulating pattern rather than an “S” shaped pattern. The middle segment344 need not have bends positioned facilitate the movement of the braid310 into a second implanted shape.

As illustrated in FIG. 8B, when in the implanted shape, the braid 310can have an outer layer 342 a shaped to contact an aneurysm wall,compressed extensions of an undulating middle layer 344 a nested withinthe outer layer 342 a, a proximal inversion 322 a positioned to beplaced an aneurysm neck, and a distal inversion 324 a positioned to beplaced near a distal portion of the aneurysm wall. The detachmentfeature 150 and pinched end 312 of the braid 310 can be positionedwithin the aneurysm sac, either near the distal inversion 324 a asillustrated, near the proximal inversion 322 a, or at a position inbetween. The detachment feature 150 and pinched end 312 can bepositioned to reduce the likelihood that the implant 300 becomesimpacted.

FIG. 9A is an illustration of an example implant 400 having a tubularbraid 410 in another alternative predetermined shape. FIG. 9B is anillustration of the example implant 400 illustrating the tubular braid410 in an implanted shape. The tubular braid 410 can have an open end414 and a pinched end 412. A detachment feature 150 can be attached tothe braid 410 at the pinched end 412. The implant 400 can be formed inthe predetermined shape, collapsed for delivery through a microcatheter,attached to a delivery system at the detachment feature 150, andimplanted in the implanted shape.

As illustrated in FIG. 9A, when in the predetermined shape, the tubularbraid 410 can include two inversions 422, 424, dividing the braid 410into three segments 442, 444, 446. In the predetermined shape, the braid410 can have an outer segment 442 extending from the open end 414 of thebraid 410 to one of the inversions 422, an inner segment 446 extendingfrom the pinched end 412 of the braid 410 to the other of the inversions424, and a middle segment 444 extending between the two inversions 422,424. When in the predetermined shape, the tubular braid 410 can besubstantially radially symmetrical about a central vertical axis y (seeFIG. 6A). FIG. 9A illustrates a profile of each segment 442, 444, 446.

Comparing the predetermined shape of the braid 410 illustrated in FIG.9A to that of the braid 110 illustrated in FIG. 1A, the outer segments142, 442 can be similar to each other, the middle segment 444 of thebraid 410 illustrated in FIG. 9A can have a less pronounced “S” shapecompared to the “S” shaped middle segment 144 illustrated in FIG. 1A,and the inner segment 446 can be conical or “V” shaped in profile withthe pinch end 412 positioned near the inversion 422 adjacent the outerlayer 442 rather than near the inversion 142 adjacent the inner layer146 as illustrated in FIG. 1A. When implanted, the inner segment 446 canreshape to form a compaction resistant column.

The tubular braid 410 illustrated in FIG. 9A can be formed into thepredetermined shape similar to as described in relation to FIG. 1A withsome differences. The middle segment 444 illustrated in FIG. 9A can beformed to have a less pronounced “S” shape pattern compared to the “S”shaped pattern 144 illustrated in FIG. 1A. The middle segment 444 neednot have bends positioned facilitate the movement of the braid 410 intoa second implanted shape. The inner segment 446 can have a longer lengthas illustrated in FIG. 9A compared to the inner segment 146 illustratedin FIG. 1A. The inversion 424 adjacent the inner segment 446 can have amore acute curvature as illustrated in FIG. 9A compared to thecorresponding inversion 124 illustrated in FIG. 1A.

As illustrated in FIG. 9B, when in the implanted shape, the braid 410can have an outer layer 442 a shaped to contact an aneurysm wall, atulip or heart shaped sack 444 a nested within the outer layer 442 a, aproximal inversion 422 a positioned to be placed at an aneurysm neck, adistal inversion 424 a positioned to be placed near a distal portion ofthe aneurysm wall, and a compaction resistant column 446 a extendingwithin the sack 444 a. The detachment feature 150 and pinched end 412 ofthe braid 410 can be positioned within the sack 444 a near the proximalinversion 422 a. The detachment feature 150 and pinched end 412 can bepositioned to reduce the likelihood that the implant 400 becomesimpacted.

FIG. 10 is an illustration of an example implant 400 having a tubularbraid 410 in a predetermined shape similar to as illustrated in FIG. 9A.

FIGS. 11A through 11E are illustrations of the example implant 400illustrated in FIG. 10 showing the tubular braid 410 expanding to theimplanted shape within a mock aneurysm 10 similar to as illustrated inFIG. 9B. As illustrated in FIG. 11A, the open end 414 can exit themicrocatheter first and expand within the aneurysm 10. As illustrated inFIG. 11B, a distal portion of the braid 410 corresponding to the outerlayer 442 in the predetermined shape can expand to appose the aneurysmwall 14 forming the outer layer 442 a in the implanted shape. Asillustrated in FIG. 11C, the braid 410 can begin to invert as the braid410 is further pushed distally from the microcatheter 600. Asillustrated in FIG. 11D, the proximal inversion 422 a can be placed atthe aneurysm neck 16 as the tulip shaped sack 444 a expands within theouter layer 442 a. As illustrated in FIG. 11E, the braid 410 can beshaped in the implanted shape within the aneurysm 10 similar to asillustrated in FIG. 9B.

Any of the implants 100, 200, 300, 400 illustrated and described hereincan include one or more additional braid layers that move substantiallyparallel to the tubular braid 110, 210, 310, 410. The multiple layerscan be stacked coaxially with each other and heat treated as a singleunit into a predetermined shape. In some applications, multiple layersmay be able to provide additional coverage at the aneurysm neck andadditional support and conformability within the aneurysm. Each onelayer of the braid can be selected with different properties withdifferent wire counts and thickness, braid angle and diameter and wirematerial to potentially increase metal coverage, reduce profile(microcatheter size), facilitate deployment and reduce neck inletchannel size while providing visibility under angiogram.

FIG. 12A is a cross sectional illustration of an implant 500 includingtwo braid layers 510, 560 in a predetermined shape similar to thatillustrated in FIG. 1A. The braid layers 510, 560 are constricted at apinched end 512 at which a detachment feature 550 can be affixed to thebraid layers 510, 560. As illustrated, in the predetermined shape, eachof the braid layers 510, 560 can have a respective open end 514, 564,first segment 542, 582, first inversion 522, 572, second segment 544,584, first bend 532, 592, second bend 534, 594, second inversion 524,574, and third segment 546, 586 similar to as described in relation tothe implant 100 illustrated in FIG. 1A. For each of the two braid layers510, 560, the third segment extends from the pinched end 512 to thesecond inversion 524, 574, the second segment 544, 584, extends from thesecond inversion 524, 574 to the first inversion and at least partiallysurrounds the third segment 546, 586, and the first segment extends 542,582 from the first inversion 522, 572 and at least partially surroundsthe second segment 544, 584. As illustrated, for each of the two layers,the first segment only partially surrounds the second segment. About thefirst inversion of each of the two layers, layer B (560) is nestedwithin layer A (510). About the second inversion of each of the twolayers, layer A is nested within layer B.

FIG. 12B illustrates the braid layers 510, 560 positioned within amicrocatheter 600. The braid layers 510, 560 can be positioned ascoaxial tubes, as illustrated, with an inner layer 560 (layer B) andouter layer 510 (layer A). Benchtop testing has demonstrated that twolayers of braid can come down to a smaller braid outer circumference (C)compared to a single layer braid with the same total wire count.Implants 100, 200, 300, 400 including a single layer tubular braid 110,210, 310, 410 preferably have a wire count of 72 wires or 96 wires. Withthe same total wire count, an implant 500 having two layers 510, 560 canreduce the braid profile size when collapsing into the delivery system.It can reduce the track force and also the microcatheter size, which canfacilitate navigability to more challenging and distal vasculature. Withthe same delivery tube size, the two layers 510, 560 of braid canincrease the total wire count that can fit in that size. The added wirecount can decrease the porosity at the neck of the aneurysm to promoteflow diversion and thrombosis at the neck to promote healing and treatruptured aneurysms more quickly. The added wires can also facilitate thedeployment of an implant in larger aneurysms in different anatomiclocations.

FIG. 12C illustrates the implant 500 implanted in a larger aneurysm 10 ain a first implanted shape similar to the implanted shape illustrated inFIG. 1B. The larger aneurysm 10 a defines a first substantiallyspherical cavity having an entrance that is the neck opening 16 a. Asillustrated, in the first implanted shape, each of the two layers havean outer layer corresponding to the first segment of the predeterminedshape and a proximal inversion corresponding to the first inversion ofthe predetermined shape. As illustrated, the outer layer 542 a of layerA 510 is positioned to contact a cavity wall 14 a of the larger aneurysm10, the outer layer 582 a of layer B 560 apposes the outer layer 542 aof layer A 510, and the proximal inversion 522 a, 572 a of each of thetwo layers 510, 560 is positioned approximate the entrance 16 a to thelarger aneurysm 10 a. As illustrated, each of the two layers 510, 560 oftubular braid comprises a sack 544 a, 584 a corresponding to the secondsegment 544, 584 of the predetermined shape. The sack 584 a of layer B560 is positioned to appose a portion of the cavity wall of the largeraneurysm 10 a. The sack 544 a of layer A 510 is contained within thesack 584 a of layer B 560.

The two layers 510, 560 can press together to potentially perform like astronger single layer braid which, in some applications can facilitateimplant deployment in an angled aneurysm. When deployed in aneurysm, theouter segments of each of the two layers expand outwardly against theaneurysm wall to stabilize the braid against the aneurysm wall.Comparing an implant having a singular braid layer to an implant havingtwo or more braid layers, the two implants having a similarly sized andshaped predetermined shape, the singular braid layer may requirerepositioning of the distal end of the catheter to facilitate inversionnear the aneurysm neck while the implant having two or more braid layersmay be inverted near the aneurysm neck by distal movement of the pinchedend without requiring repositioning of the distal end of the catheter.The added wire counts can also increase the conformability and supportat the aneurysm dome.

The two layers can also potentially increase chronic outward force tosupport the inner braid against the outer braid and resist compaction.As illustrated in FIG. 5A, a single layer braid 110 can provide a radialforce F against the aneurysm wall 14 a. Similarly, two layers 510, 560of braid as illustrated in FIG. 12C can provide a radial force F againstthe aneurysm wall 14 a that is greater than the single layer braid 110,all else being equal. In other words, given an implant 100 having asingle layer braid 110 formed in a predetermined shape, having a totalwire count, each wire having a wire circumference, and used to treat ananeurysm 10 a and also given an implant 500 having two layers 510, 560of braid, a total wire count equal to that of the single layer braid110, an average wire circumference about equal to the wires of thesingle layer braid 110, and used to treat the same aneurysm or aneurysmof substantially identical size 10 a, the two layers 510, 560 canprovide a greater radial force F against the aneurysm wall 14 a comparedto the single layer 110.

FIG. 12D illustrates the implant 500 implanted in a smaller aneurysm 10b in a second implanted shape similar to the implanted shape illustratedin FIG. 1C. The smaller aneurysm 10 b defines a second substantiallyspherical cavity having an entrance that is the neck opening 16 b. Asillustrated, in the second implanted shape, each of the two layers 510,560 has an outer layer 542 b, 582 b corresponding to the first segment542, 582 of the predetermined shape and a proximal inversion 522 b, 572b corresponding to the first inversion 522, 572 of the predeterminedshape. The outer layer 542 b of layer A 510 contacts the cavity wall 14b of the smaller aneurysm 10 b. The outer layer 582 b of layer B 560apposes the outer layer 542 b of layer A 510. The proximal inversion 522b, 572 b of each of the two layers is placed approximate the entrance 16b to the second substantially spherical cavity 10 b. Each of the twolayers of tubular braid have a middle layer 544 b, 584 b and inner layer546 b, 586 b corresponding to the second segment 544, 584 of thepredetermined shape and a fold 524 b, 564 b separating the middle andinner layer. The inner layer 586 b of layer B 560 apposes the innerlayer 546 b of layer A 510 which apposes the middle layer 544 b of layerA 510 which apposes the middle layer 584 b of layer B 560 which apposesthe outer layer 582 b of layer B 560.

In the predetermined shape illustrated in FIG. 12A, each of the twolayers 510, 560 of tubular braid comprises one or more bends 532, 534,592, 594 positioned in the respective second segment 544, 584. In thesecond implanted shape illustrated in FIG. 12D, for each of the twolayers 510, 560, the fold 524 b, 574 b separating the middle layer 544b, 584 b and the inner layer 546 b, 586 b corresponds to one of thebends in the second segment of the predetermined shape.

In the first implanted shape illustrated in FIG. 12C, the pinched end512 is suspended within the sacks 544 a, 584 a of layer A 510 and layerB 560. In the second implanted shape illustrated in FIG. 12D, thepinched end 512 is encircled by the proximal inversions 522 a, 572 a oflayer A 510 and layer B 560.

In the first implanted shape illustrated in FIG. 12C, the two layers510, 560 form an open end 514, 564 that encircles the sack 544 a, 584 a.In the second implanted shape illustrated in FIG. 12D, the open end 514,564 encircles the fold 524 b, 574 b for each of the two layers 510, 560.

The implant 500 can be delivered and implanted following steps similarto those illustrated in FIGS. 3A through 3G. The implant 500 can bepositioned within an aneurysm/spherical cavity solely via manipulationof the pinched end and positioning of the distal end of the catheter. Adistal end of a catheter can be positioned near an aneurysm neck/cavityentrance. The pinched end 512 of the implant 500 can be pushed distallyto push the implant 500 through at least a portion of the catheter 600.The outer layer 542 a, 542 b of layer A 510 can be apposed to theaneurysm wall 14. The outer layer 582 a, 582 b of layer B 560 can beapposed to the outer layer 542 a, 542 b of layer A 510. For at least thefirst implanted shape, a sack 584 a can be formed from layer B 560 thatis at least partially surrounded by the outer layers 542 a, 582 a oflayer A and layer B and a sack 544 a can be formed from layer A 510 thatis at least partially surrounded by the outer layers of layer A andlayer B and contained within the sack of layer B. The pinched end can bedisengaged while two layers 510, 560 each retain their respective sacks544 a, 584 a to leave the implant 500 implanted in the first implantedshape. For at least the second implanted shape, the second segment 544,584 of each of the two layers 510, 560 in the second implanted shape canbe folded to form the inner layer 546 b, 586 b and middle layer 544 b,584 b separated by the fold 524 b, 574 b such that that the inner layer586 b of layer B 560 apposes the inner layer 546 b of layer A 510 whichapposes the middle layer 544 b of layer A 510 which apposes the middle584 b layer of layer B 560 which apposes the outer layer 582 b of layerB 560.

By virtue of having two implanted shapes, similar to the implant 100illustrated in FIGS. 1A through 1C, the implant 500 illustrated in FIGS.12A through 12D can be suitable (via appropriate jurisdictionalrequirements for medical devices) for treating a first aneurysm having afirst diameter measuring about 4 mm and a first height measuring about 6mm, a second aneurysm comprising a second diameter measuring about 5 mmand a second height measuring about 8 mm, and a third aneurysmcomprising a third diameter measuring about 6 mm and a third heightmeasuring about 6 mm. Also, by virtue of having two implanted shapes,similar to the implant 100 illustrated in FIGS. 1A through 1C, theimplant 500 illustrated in FIGS. 12A through 12D can be suitable fortreating aneurysms within a continuum of aneurysm sizes, the continuumbounded by and including diameters between about 4 mm and about 5 mm andheights between about 6 mm and about 8 mm.

FIG. 13 illustrates a cross section of another implant 700 having twobraid layers 710, 760 in a predetermined shape. The implant 700 isformed to the predetermined shape 700 similar to the implants 100, 500illustrated in FIGS. 1A and 12A. The implant 700 illustrated in FIG. 13differs primarily from the implant 500 illustrated in FIG. 12A in thearea of the neck channel 526, 716.

Including two or more braid layers can potentially decrease the innerneck channel size for devices made of Nitinol-platinum wire woven braid.In other words, for a substantially identical process of achieving apredetermined shape, the neck channel opening 526, 726 of an implant500, 700 having two layers 510, 710, 560, 760 can be smaller than theneck channel opening 126 of an implant 100 having a single braid layer110. Similarly, when implanted, the neck channel opening 526 aillustrated in FIG. 12C can be smaller than the neck channel opening 126a illustrated in FIG. 1B and further smaller for neck channel 726 inFIG. 13. A neck channel having a large opening can allow constant bloodflow to reach the aneurysm neck and slow down healing. Platinum wiresadded to a braid generally make the braided portion of the respectiveimplant visible under angiogram. However, because the platinum wire doesnot retain its shape as well as the nitinol wire after heat treatment,when deployed, a nitinol-platinum braid device is expected to have abigger neck channel opening compared to an all nitinol braid (where thenitinol-platinum braid and the all nitinol braid have substantiallyidentical predetermined shapes).

Depending on the specific needs and braid properties, in an implantincluding two or more braid layers, an all nitinol braid can be used incombination with a nitinol-platinum braid such that the nitinol-platinumbraid facilitates visualization of the braided portion of the braid andthe all nitinol braid facilitates movement of the braid layers to thepredetermined shape. The all nitinol braid can either be used as theinside or outside braid to reduce the inner channel size when fabricatedwith nitinol-platinum braid. FIG. 12A illustrates an implant 500 havingan all nitinol braid is positioned outside during delivery, layer A 510,and a nitinol-platinum braid positioned on the inside during delivery,layer B 560. When deployed, the nitinol braid 510 can create a smallneck inner channel 526 a and can cover a larger channel of anitinol-platinum braid 560. FIG. 13 illustrates an implant 700 having anall nitinol braid positioned as layer B 760 and a nitinol-platinum braidpositioned as layer A 710. When deployed, the nitinol braid 760 cancinch down on the nitinol-platinum braid 710 and create a double layeredneck channel 726 that is smaller than the opening of the neck channel126 with a nitinol-platinum braid alone 110 as illustrated in FIG. 1A.

Referring to FIG. 13, the braid layers 710, 760 are constricted at apinched end 712 at which a detachment feature 750 can be affixed to thebraid layers 710, 760. As illustrated, in the predetermined shape, eachof the braid layers 710, 760 can have a respective open end 714, 764,first segment 742, 782, first inversion 722, 772, second segment 744,784, first bend 732, 792, second bend 734, 794, second inversion 724,774, and third segment 746, 786 similar to as described in relation tothe implant 100 illustrated in FIG. 1A and in relation to the implant500 illustrated in FIG. 12A. For each of the two braid layers 710, 760,the third segment 746, 786 extends from the pinched end 712 to thesecond inversion 724, 774, the second segment 744, 784, extends from thesecond inversion 724, 774 to the first inversion and at least partiallysurrounds the third segment 746, 786, and the first segment 742, 782extends from the first inversion 722, 772 and at least partiallysurrounds the second segment 744, 784. As illustrated, for each of thetwo layers 710, 760, the first segment 742, 782 only partially surroundsthe respective second segment 744, 784. About the first inversion 722,772 of each of the two layers, layer B 760 is nested within layer A 710.About the second inversion 724, 774 of each of the two layers, layer A710 is nested within layer B 760.

The implant 700 can be delivered through a catheter 600 similar to asillustrated in FIG. 12B. The implant can be positioned through stepssimilar to as illustrated in FIGS. 3A through 3G and described inrelation to FIGS. 12A through 12D. The implant 700 can be implanted intwo distinct implanted shapes similar to as illustrated in FIGS. 12C and12D.

FIG. 14 illustrates a cross section of another implant 800 having twobraid layers 810, 860 in a predetermined shape. The implant 800 has apredetermined shape similar to that illustrated in FIG. 7A, a differencebeing the implant 800 illustrated in FIG. 14 has two tubular braidlayers while the implant illustrated in FIG. 7A has one tubular braid.The implant 800 illustrated in FIG. 14 also has a predetermined shapesimilar to that illustrated in FIG. 12A, a difference being the implant800 illustrated in FIG. 14 includes a dual layer compaction resistantpost formed from inner segments 846, 886 of the braid 810.

The braid layers 810, 860 are constricted at a pinched end 812 at whicha detachment feature 850 can be affixed to the braid layers 810, 860. Asillustrated, in the predetermined shape, each of the braid layers 810,860 can have a respective open end 814, 864, first segment 842, 882,first inversion 822, 872, second segment 844, 884, first bend 832, 892,second bend 834, 894, second inversion 824, 874, and third segment 846,886 similar to as described in relation to the implant 100 illustratedin FIG. 1A and in relation to the implant 500 illustrated in FIG. 12A.For each of the two braid layers 810, 860, the third segment 846, 886extends from the pinched end 812 to the second inversion 824, 874, thesecond segment 844, 884, extends from the second inversion 824, 874 tothe first inversion and at least partially surrounds the third segment846, 886, and the first segment 842, 882 extends from the firstinversion 822, 872 and at least partially surrounds the second segment844, 884. As illustrated, for each of the two layers 810, 860, the firstsegment 842, 882 only partially surrounds the respective second segment844, 884. About the first inversion 822, 872 of each of the two layers,layer B 860 is nested within layer A 810. About the second inversion824, 874 of each of the two layers, layer A 810 is nested within layer B860.

The two layers 810, 860 of tubular braid can be stabilized in animplanted shape based on the predetermined shape illustrated in FIG. 14when the braid layers 810, 860 are constrained by a substantiallyspherical cavity such as the interior of an aneurysm. In the implantedshape, layer A 810 has an outer layer corresponding to the first segment842 that apposes the cavity wall of the substantially sphericalcavity/aneurysm, layer B 760 has and outer layer corresponding to thefirst segment 882 that apposes to the outer layer of layer A 810, layerB 860 has an inner sack corresponding to the middle segment 884 thatapposes to the outer layer of layer B 860, layer A 810 has an inner sackcorresponding to the middle segment 844 positioned within the inner sackof layer B 860, for each of the two layers 810, 860, a proximalinversion corresponding to the first inversion 822, 872 is positionedapproximate an entrance to the substantially spherical cavity/aneurysmneck, for each of the two layers 810, 860, a distal inversioncorresponding to the second inversion 824, 874 is positioned approximatea distal portion of the cavity wall, and each of the two layers 810, 860has a post corresponding to the third segment 846, 886, the postextending centrally within the inner sack and along a majority of alength between the distal inversion and the proximal inversion such thatthe post of layer B is positioned within the post of layer A.

The implant 800 can be delivered and implanted similar to as describedin relation to the first implanted shape of the implant 500 illustratedin FIGS. 12A through 12C with a difference being that the pinched end812 of the implant 800 illustrated in FIG. 15 can be positioned near theaneurysm neck, a tubular segment of layer A corresponding to the thirdsegment 846 can be extended within the sack of layer A 810 and the sackof layer B 860 to terminate at the pinched end 812, and a tubularsegment of layer B 860 corresponding to the third segment 886 can beextended within the tubular segment of layer A 810 to terminate at thepinched end 812.

Although not illustrated, the implants 300, 400 illustrated in FIGS.8A-B, 9A-B, 10, and 11A-E can alternatively include two or more braidlayers according to the principles illustrated and described in relationto FIGS. 12A-D, 13, and 14. Further, each implant 100, 200, 300, 400,500, 700, 800 can include a total of two, three, four, or five braidlayers.

FIGS. 15A to 15C are illustrations of an example tubular implant 900that can have a predetermined shape. The implant 900 can treat a rangeof aneurysm sizes. The implant 900 can include a tubular braid 910having an open end 914 and a pinched end 912. The predetermined shape isthe expanded shape of the tubular braid 910 when the braid 910 is notconfined by a delivery catheter. When implanted, the braid 910 is in animplanted shape, which is based at least in part on the predeterminedshape and the anatomy of the aneurysm 10. The tubular braid 910 can becomposed of one or more wires.

The implant 900 can include a connection and detachment feature 150attached to the braid 910 at the pinched end 912. The pinched end 912can include a marker band and/or soldered point with visibility, and/orthe connection feature 150 can include radiopaque material. The tubularbraid 910 can be formed in a predetermined shape (FIGS. 15A to 15C),collapsed for delivery through a microcatheter, attached to a deliverysystem at the connection feature 150, and implanted in an implantedshape such as the ones shown in FIGS. 16A and 16B.

Referring to FIGS. 15A through 15C, when in a predetermined shape, thetubular braid 910 can include an inversion 922, a pinched end 912, andan open end 914. The tubular braid can include two segments, 942 and944. The first segment 942 can extend from the open end 914 of thetubular braid 910 to a proximal inversion 922. The second segment 944can be at least partially surrounded by the open end 914 and can extendfrom the proximal inversion 922 to the pinched end 912. The secondsegment, as shown in FIGS. 15A to 15C, can also include at least onecorrugated fold 950. The first segment, as shown in FIGS. 15B and 15C,can also include at least one corrugated fold 960. The corrugated folds950, 960 can be configured to assist in anchoring the device when in animplanted shape (e.g. FIGS. 16A and 16B) within an aneurysm 10. Thecorrugated folds can act in a similar manner to stent struts to help thetubular braid 910 hold its predetermined or implanted shape.

When in a predetermined shape, the tubular braid 910 can besubstantially radially symmetrical about a central vertical axis. Thetubular braid can be formed into a predetermined shape by inverting thebraid inwardly to separate the second segment 944 from the first segment942. The tubular braid 910 can include memory shape material that can beheat set to the predetermined shape. This heat-set material can beutilized to form one or more corrugations 950, 960 in the first and/orsecond segments 942, 944.

As illustrated in FIG. 16C, the one or more wires of the tubular braid910 making up the corrugated folds 950, 960 can be compressed orflattened along a vertical axis, resulting in a smaller wire diameteralong the vertical axis of the corrugated fold 950, 960 relative to thenon-compressed portions of the tubular braid 910. The compressedportions of the wires making up the corrugated folds 950, 960 can alsohave a different cross-sectional shape relative to non-compressedportions of wire in the tubular braid 910. For instance, thenon-compressed portions of wire can be circular, while the compressedportions can be ellipsoid in shape. Flattening the one or more wiresmaking up the corrugated folds 950, 960 can make these portions of thetubular braid 910 more rigid, thereby assisting in maintaining the shapeof the tubular braid 910 and anchoring it within an aneurysm. Bycompressing the wires, the wires are no longer able to bend or flexequally in all directions. Preferably, flattening the one or more wiresmaking up the corrugated folds 950, 960 can make the wires bendable intwo opposite directions. Therefore, portions of the braid 910constructed with flattened wires, such as corrugated folds 950, 960 canbe more resistant to bending relative to non-flattened wires in theremainder of the braid.

The tubular braid 910 can be deformed for delivery through a catheterand can self-expand to an implanted shape (e.g., FIGS. 16A and 16B) thatis based on a predetermined shape and confined by the anatomy of theaneurysm in which it is implanted. When the tubular braid 910 is in thepredetermined shape, at least one corrugated fold 950 in the secondsegment 944 can appose the first segment 942 or a corrugated fold 960 inthe first segment 942, thereby exerting an outwardly radial force on thefirst segment 942.

The tubular braid 910 in the implanted shape can be radially orvertically compressed or extended compared to the predetermined shape.Compressing the tubular braid 910 can cause the folds in the inner layer950 a to provide a force against the first segment 942 a and/or acorrugated fold in the first segment 960 a. This compression can alsocause the corrugated folds 960 a in the first segment 942 a to apply aradial force against the aneurysm wall 14.

FIG. 16A illustrates the predetermined shape in FIG. 15A as implantedinto an aneurysm. In the implanted shape in FIG. 16A, the braid 910 canhave an outer layer 942 a corresponding to the first segment 942 of thepredetermined shape and positioned to contact an aneurysm wall 14 of theaneurysm 10. A proximal inversion 922 a can correspond to the proximalinversion 922 of the predetermined shape and positioned to be placedapproximate a neck 16 of an aneurysm 10. An inner layer 944 a cancorrespond to the second segment 944 of the predetermined shape. Thetubular braid 910 can have at least one corrugated fold 950 a in theinner layer corresponding to the at least one corrugated fold in thesecond segment of the predetermined shape.

When the tubular braid 910 is in the implanted shape within an aneurysm10, at least one corrugated fold in the inner layer 950 a can appose atleast a portion of the outer layer 942 a, thereby exerting an outwardlyradial force on the outer layer 942 a to anchor the implant 900 withinthe aneurysm 10. The wire of the tubular braid 910 comprising thecorrugated folds 950 a in the inner layer 942 a can be flattened asdescribed in FIGS. 15A to 15C and shown in FIG. 16C to increase therigidly of the corrugations and assist with anchoring the tubular braid910 within the aneurysm 10.

In FIG. 16B, the predetermined shape of FIG. 15B is in the implantedshape. In this implanted shape, the tubular braid 910 can also have atleast one corrugated fold in the outer layer 960 a corresponding to theat least one corrugated fold in the first segment of the predeterminedshape. The corrugated folds of the inner layer 950 a can be formed in aposition such that they appose corrugated folds in the outer layer 960 awhen in the implanted shape. The corrugated folds of the outer layer 960a provide an outwardly radial force in a plane defining a boundarybetween the aneurysm 10 and a blood vessel 22 a, 22 b, the forcesufficient to appose the outer layer 942 a to walls 14 of the aneurysm10 and anchor the implant 900 within the aneurysm. Further, asillustrated in FIG. 16B, the wire of the tubular braid 910 comprisingthe corrugated folds 960 a in the outer layer 942 a can also beflattened as shown in FIG. 16C to increase the rigidly of thecorrugations and assist with anchoring the tubular braid 910 within theaneurysm 10.

A method for forming an implant 900 to treat an aneurysm can includepositioning a distal end of a catheter approximate a neck 16 of ananeurysm 10, pushing a pinched end 912 of a tubular braid 910 having oneor more wires and an open end 914 distally through at least a portion ofthe catheter, positioning the open end 914 within a sac 12 of theaneurysm 10; and deploying the tubular braid 910 to an implanted shapewithin the aneurysm based upon a predetermined shape. The implant 900can be deployed to an implanted shape within the aneurysm based upon apredetermined shape by inverting the tubular braid 910 to form aproximal inversion 922 a by moving the open end 914 over at least aportion of the braid 910, shaping an outer layer 942 a of the tubularbraid 910 extending between the open end 914 and the proximal inversion922 a, and shaping an inner layer of the tubular braid 944 a extendingbetween the proximal inversion 922 a and the pinched end 912, wherein atleast one corrugated fold 950 a is located within the inner layer 944 a.

The method can further include positioning the implant within theaneurysm sac solely via manipulation of the pinched end and viapositioning of the distal end of the catheter. The outer layer can alsoinclude at least one corrugated fold 960 a within the outer layer 942 a.When implanted, at least one corrugated fold 950 a within the innerlayer 944 a can provide an outwardly radial force against the outerlayer 942 a, against a corrugated fold in the outer layer 960 a in aplane defining a boundary between the aneurysm 10 and a blood vessel 22,or both. The force can be sufficient to appose the outer layer 942 a towalls 14 of the aneurysm 10. In a similar manner, the corrugated folds960 a of the outer layer 942 a can provide an outwardly radial force ina plane defining a boundary between the aneurysm 10 and a blood vessel22, the force sufficient to appose the outer layer 942 a to walls 14 ofthe aneurysm 10.

The wire of the tubular braid 910 comprising the at least one corrugatedfolds can be compressed along a vertical axis such that the diameter ofthe corrugated fold along the axis is lesser than the diameter of theuncompressed portions of the tubular braid 910. This compression canincrease the rigidity of the at least one corrugated fold relative tothe rest of the braid.

Although not illustrated, the implants 100, 200, 300, 400, 500, 600,700, 800 illustrated in prior figures can alternatively include acombination of round and flattened wires according to the principlesillustrated and described in relation to FIGS. 15A-C and 16A-C.

The tubular braid 110, 210, 310, 410, 510, 560, 710, 760, 810, 860, 910of the example implants 100, 200, 300, 400, 500, 700, 800, 900 caninclude memory shape material that can be heat set to a predeterminedshape, can be deformed for delivery through a catheter, and canself-expand to an implanted shape that is based on the predeterminedshape and confined by the anatomy of the aneurysm in which it isimplanted. Tubular braid can further include platinum wire strands,markers, or other radiopaque features.

The example implants 100, 200, 300, 400, 500, 700, 800, 900 describedherein can rely on a radial outward force to anchor the implant withinthe sac of an aneurysm. To this end, the braid(s) 110, 210, 310, 410,510, 560, 710, 760, 810, 860, 910 can be shaped to a predetermined shapehaving a diameter (diameter of outermost braid, radially, for implantshaving multiple braid layers) that is greater than its height (betweendistal most layer and proximal most layer for implants having multiplebraid layers) so that the braid is radially constricted when implantedin an aneurysm. The ratio of diameter to height of the braid(s) 110,210, 310, 410, 510, 560, 710, 760, 810, 860, 910 in a respectivepredetermined shape can be within the range of 2:1 to 1:3 to treataneurysms of many known sizes and shapes.

As used herein, the terms “about” or “approximately” for any numericalvalues or ranges indicate a suitable dimensional tolerance that allowsthe part or collection of components to function for its intendedpurpose as described herein. More specifically, “about” or“approximately” may refer to the range of values ±20% of the recitedvalue, e.g. “about 90%” may refer to the range of values from 71% to99%.

The descriptions contained herein are examples of embodiments of theinvention and are not intended in any way to limit the scope of theinvention. As described herein, the invention contemplates manyvariations and modifications of the implant, including alternativematerials, alternative geometries, alternative detachment features,alternative delivery systems, alternative means for forming a braid intoa predetermined shape, alternative treatment methods, alternative numberof braid layers, etc. These modifications apparent to those havingordinary skill in the art to which this invention relates are intendedto be within the scope of the claims which follow.

What is claimed is:
 1. An implant comprising: a tubular braid comprisingone or more wires, an open end and a pinched end, the tubular braidfurther comprising a predetermined shape in which the tubular braidcomprises: a first segment extending from the open end to a proximalinversion, a second segment at least partially surrounded by the firstsegment, and at least one corrugated fold in the second segment.
 2. Theimplant of claim 1, wherein the cross-sectional shape of the one or morewires forming the at least one corrugated fold is different from thecross-sectional shape of the one or more wires forming the remainder ofthe second segment.
 3. The implant of claim 1, wherein the at least onecorrugated fold in the second segment apposes the first segment.
 4. Theimplant of claim 1, wherein the first segment comprises at least onecorrugated fold, the cross-sectional shape of the one or more wiresforming the at least one corrugated fold of the first segment beingdifferent than the cross-sectional shape of the one or more wiresforming the remainder of the first segment.
 5. The implant of claim 4,wherein the one or more wires forming the at least one corrugated foldof the first segment are compressed along an axis such that the diameterof the compressed corrugated fold portion along the axis is lesser thanthe diameter of the uncompressed portions of the tubular braid.
 6. Theimplant of claim 4, wherein the tubular braid is in an implanted shapebased on the predetermined shape when constrained by a substantiallyspherical cavity.
 7. The implant of claim 6, wherein the tubular braidin the implanted shape comprises an outer layer corresponding to thefirst segment of the predetermined shape, a proximal inversioncorresponding to the first inversion of the predetermined shape, aninner layer corresponding to the second segment of the predeterminedshape, at least one corrugated fold in the inner layer corresponding tothe at least one corrugated fold in the second segment of thepredetermined shape, the cross-sectional shape of the one or more wiresforming the at least one corrugated fold in the inner layer beingdifferent than the cross-sectional shape of the one or more wiresforming the remainder of the inner layer, and at least one corrugatedfold in the outer layer corresponding to the at least one corrugatedfold in the first segment of the predetermined shape.
 8. The implant ofclaim 7, wherein the outer layer is positioned to contact the wall ofthe aneurysm, and the proximal inversion is positioned to be approximatea neck of the aneurysm.
 9. The implant of claim 8, wherein at least onecorrugated fold in the inner layer apposes at least a portion of theouter layer.
 10. The implant of claim 8, wherein the at least onecorrugated fold in the inner layer apposes at least one corrugated foldin the outer layer.
 11. The implant of claim 7, wherein the one or morewires forming the at least one corrugated fold of the outer layer arecompressed along an axis such that the diameter of the compressedcorrugated fold portion along the axis is lesser than the diameter ofthe uncompressed portions of the tubular braid.
 12. The implant of claim11, wherein the one or more corrugated folds of the outer layer providean outwardly radial force in a plane defining a boundary between theaneurysm and a blood vessel, the force sufficient to appose the outerlayer to walls of the aneurysm.
 13. A method comprising: positioning adistal end of a catheter approximate a neck of an aneurysm; pushing apinched end of a tubular braid further comprising an open end and one ormore wires distally through at least a portion of the catheter;positioning the open end within a sac of the aneurysm; and deploying thetubular braid to an implanted shape within the aneurysm based upon apredetermined shape as follows: inverting the tubular braid to form aproximal inversion by moving the open end over at least a portion of thebraid; shaping an outer layer of the tubular braid extending between theopen end and the proximal inversion; and shaping an inner layer of thetubular braid extending between the proximal inversion and the pinchedend, wherein the inner layer comprises at least one corrugated fold. 14.The method of claim 13, wherein the one or more wires in the at leastone corrugated fold of the inner layer are compressed along an axis suchthat the diameter of the wire in the corrugated fold along the axis islesser than the diameter of the uncompressed portions of the tubularbraid.
 15. The method of claim 13, further comprising apposing at leasta portion of the outer layer with at least one corrugated fold formedwithin the inner layer.
 16. The method of claim 13, wherein the outerlayer comprises at least one corrugated fold.
 17. The method of claim16, further comprising apposing the walls of the aneurysm with at leastone corrugated fold formed in the outer layer.
 18. The method of claim16, further comprising apposing at least one corrugated fold within theouter layer with at least one corrugated fold within the inner layer.19. The method of claim 16, wherein the one or more wires in the atleast one corrugated fold of the outer layer are compressed along anaxis such that the diameter of the wire in the corrugated fold along theaxis is lesser than the diameter of the uncompressed portions of thetubular braid.
 20. The method of claim 19, wherein compressing the wirescomprising the at least one corrugated fold of the outer layer along anaxis increases the rigidity of the at least one corrugated fold relativeto the rest of the braid.